Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer

Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The test is currently not reimbursed by the Swiss health insurances.

The proposed study will investigate to what extent adjuvant treatment recommendations in breast cancer patients with an ER-positive tumor, made by Swiss tumor boards, are based on conventional factors, and whether the recommendations would change, when RS results from the Oncotype DX® test were available.

In addition this study approaches the dilemma of adding adjuvant CT to adjuvant endocrine therapy in a systematic fashion. In this study, the St. Gallen consensus 2009 (with a minor update from the 2011 consensus, is used to predefine the patients suitable for endocrine therapy or chemo-endocrine therapy. Once results of this study are available they may help to better integrate Oncotype DX® with other factors. Currently, it is unclear how the different factors should be integrated into one recommendation.

This study will provide data on the usefulness of this test for the two patient groups which are suitable for hormone therapy only and for those who are considered for hormone plus chemotherapy.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kantonsspital Baden, Baden, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients screening criteria

≥ 18 years old female patients.
Resected primary breast cancer (R0 resection).
ER-positive breast cancer (defined as at least 10% ER-positive malignant cells).
HER2 negativity by IHC (0 or 1+) or by FISH (negative if ratio is ≤ 2.0).
pN0 or pN1a (1-3 positive nodes) by sentinel procedure or axillary dissection.

All patients matching the screening criteria should be recorded consecutively in the patient screening and enrollment list.

Patients inclusion criteria for baseline data collection

Signed informed consent form for participation to the baseline data collection.

In addition, the following information must be available from the pathology report:

Estimation of the pathologic maximum tumor diameter (in mm).
Results of ER positive tumor cells (in %) and of PgR positive tumor cells (in %) of the invasive component.
Proliferation rate by Ki-67 staining (MIB-1 antibody) in %.
Result of modified Bloom-Richardson-Elston (BRE) Grading (Grade 1, 2 or 3).

Patients eligibility criteria for participation to the study Inclusion criteria

Signed informed consent form for participation to the study SAKK 26/10.
The patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy).
Invasive breast cancer tissue is available to prepare 39 sections (35 unstained + 4 H&E stained slides, thickness of 5 µm).
Performance Status: 0 or 1.

Exclusion criteria

Pregnancy
Bilateral invasive breast cancer
cT4 and pT4 tumors.
Patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.
Known metastatic breast cancer (M1).

Treatment and study plan

Primary outcomes

The decision change between the first and second tumor board adjuvant treatment recommendation

Time frame: 1 month

Secondary outcomes

The decision change between first and second shared decision about adjuvant treatment

Time frame: 3 weeks
The decision change between first shared decision and treatment actually given

Time frame: Between 1 and 3 months

Sponsors and collaborators

Lead sponsor

Swiss Cancer Institute

Other

Registry information

Official study title

Impact of Recurrence Score® on Recommendations for Adjuvant Treatment in Patients With ER-positive Breast Cancer

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Aug 21, 2013
Registry last updated: May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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